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Florida Administrative Code (Last Updated: April 18, 2024) |
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61. Department of Business and Professional Regulation |
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61N. Drugs, Devices and Cosmetics |
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61N-1. Regulations For Drugs, Devices And Cosmetics |
1(1) Establishments where devices or over-the-counter drugs are manufactured, packaged, repackaged, stored, held, sold, offered for sale, exposed for sale, or kept for sale or use must do so under proper conditions of temperature as required by the manufacturer’s labeling of the product or according to the U.S.P. If no temperature requirements as described above are indicated, over-the-counter drugs must be stored at temperatures no higher or lower than room temperature as defined in the U.S.P.
77(2) Establishments where devices or over-the-counter drugs are manufactured, packaged, repackaged, stored, stocked, distributed, used, sold, offered for sale, exposed for sale, or kept for sale or use shall maintain a “quarantine” section for those products which are deteriorated, outdated, misbranded, or otherwise unfit for use. This “quarantine” section shall be clearly marked and designated separate and apart from other sections so that products therein shall not be confused with usable products. Any device or over-the-counter drug stored outside of the quarantine area will be considered as a product held for sale or other distribution. A person who handles both prescription drugs and devices or over-the-counter drugs may have one quarantine section; however, the storage requirements for prescription drugs must be followed.
199(3) Every person receiving devices or over-the-counter drugs except through a retail sale has a duty to examine the product to prevent acceptance of devices or over-the-counter drugs that are adulterated, misbranded or otherwise unfit for distribution or use.
238(4) Establishments in which devices or over-the-counter drugs are manufactured, packaged, repackaged, stored, held, sold, offered for sale, exposed for sale, or kept for sale or use must be maintained in a clean and orderly manner to prevent the products from becoming contaminated with filth or injurious to health.
287Rulemaking Authority 289499.05 FS. 291Law Implemented 499.004, 294499.006, 295499.007, 296499.013 FS. History–New 7-1-96, Formerly 10D-45.05355, Amended 1-26-99, Formerly 30564F-12.014.
